CompletedPhase 1

Study to Evaluate the Safety and Tolerability of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)

11 participantsStarted 2014-02

Plain-language summary

The purpose of this study is to confirm that the local anesthetic applied to subjects with Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b study.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female subjects aged \>/=18 years at the time of the Screening Visit.
✓. Symptoms of intermetatarsal neuroma for at least 30 days prior to the Screening Visit.
✓. Diagnosis of intermetatarsal neuroma (Morton's neuroma) based on medical history and physical examination with evidence of focal tenderness and pain in the area of the neuroma, confirmed by ultrasound or other imaging modality. Typically the subject will have sensory symptoms in the distribution of the affected common digital nerve. However, provided the imaging study is positive, the presence of these sensory symptoms is not required. The neuroma may be in either the second or third intermetatarsal space.
✓. An average pain score of 4.0 to 9.0 (during the 7 days prior to dosing) on the Numeric Pain Rating Scale (NPRS), as rated daily at bedtime for average pain while walking in the last 24 hours, relevant to the affected foot. At least 4 of 7 scores during the week prior to dosing must be recorded.
✓. For female subjects: reproductive status is such that the subject is surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control; if of child-bearing potential, is not pregnant (negative urine pregnancy test prior to enrollment), is not planning to get pregnant during the course of the study, and is not lactating.
✓. Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and diaries, and to communicate meaningfully with the study personnel.
✓. Signed an Informed Consent Form approved by the Institutional Review Board.

Exclusion criteria

✕. Clinically significant bursitis or another significant symptomatic condition in the region of or adjoining the neuroma.
✕. The subject has more than one intermetatarsal neuroma on the foot to be injected (index foot).
✕. Prior use of injection with a sclerosing agent such as alcohol or phenol, or prior surgery for intermetatarsal neuroma on the affected foot.
✕. Prior injection of corticosteroid in the index foot or oral use of corticosteroids within 30 days of screening.
✕. The subject has another painful condition that, in the judgment of the investigator, would interfere with the subject's ability to evaluate the pain and functional limitations that arise from the intermetatarsal neuroma.
✕. Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis, etc.) or evidence of clinically meaningful ischemia which in the opinion of the investigator would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma. For example, if the subject has pain from a bunion but that pain is easily distinguished by the subject from the neuroma pain, then the subject would still be a candidate for the study. Note, however, that the subject should also be able to distinguish the neuroma pain from the bunion pain in terms of foot function. In general, if another foot pain condition (in the same foot) gives rise to pain that is greater than the neuroma pain, then that subject should in most instances be excluded.
✕. Signs of arterial insufficiency in the feet.
✕. Ulcer and/or wound in the foot affected by the neuroma.

What they're measuring

Evaluate the safety and tolerability of a single injection of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events

Timeframe: up to 6 months post injection

Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests

Timeframe: up to 2 weeks post injection

Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in sensory and motor examination of the foot

Timeframe: up to 6 months post injection

Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes at injection site by Injection site assessment 5-point scale for erythema and edema

Timeframe: 1, 2, and 4 hours post injection

Trial details

NCT IDNCT02550756

SponsorCentrexion Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

View on ClinicalTrials.gov More Morton's Neuroma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female subjects aged \>/=18 years at the time of the Screening Visit.
✓. Symptoms of intermetatarsal neuroma for at least 30 days prior to the Screening Visit.
✓. Diagnosis of intermetatarsal neuroma (Morton's neuroma) based on medical history and physical examination with evidence of focal tenderness and pain in the area of the neuroma, confirmed by ultrasound or other imaging modality. Typically the subject will have sensory symptoms in the distribution of the affected common digital nerve. However, provided the imaging study is positive, the presence of these sensory symptoms is not required. The neuroma may be in either the second or third intermetatarsal space.
✓. An average pain score of 4.0 to 9.0 (during the 7 days prior to dosing) on the Numeric Pain Rating Scale (NPRS), as rated daily at bedtime for average pain while walking in the last 24 hours, relevant to the affected foot. At least 4 of 7 scores during the week prior to dosing must be recorded.
✓. For female subjects: reproductive status is such that the subject is surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control; if of child-bearing potential, is not pregnant (negative urine pregnancy test prior to enrollment), is not planning to get pregnant during the course of the study, and is not lactating.
✓. Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and diaries, and to communicate meaningfully with the study personnel.
✓. Signed an Informed Consent Form approved by the Institutional Review Board.

Exclusion criteria

✕. Clinically significant bursitis or another significant symptomatic condition in the region of or adjoining the neuroma.
✕. The subject has more than one intermetatarsal neuroma on the foot to be injected (index foot).
✕. Prior use of injection with a sclerosing agent such as alcohol or phenol, or prior surgery for intermetatarsal neuroma on the affected foot.
✕. Prior injection of corticosteroid in the index foot or oral use of corticosteroids within 30 days of screening.
✕. The subject has another painful condition that, in the judgment of the investigator, would interfere with the subject's ability to evaluate the pain and functional limitations that arise from the intermetatarsal neuroma.
✕. Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis, etc.) or evidence of clinically meaningful ischemia which in the opinion of the investigator would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma. For example, if the subject has pain from a bunion but that pain is easily distinguished by the subject from the neuroma pain, then the subject would still be a candidate for the study. Note, however, that the subject should also be able to distinguish the neuroma pain from the bunion pain in terms of foot function. In general, if another foot pain condition (in the same foot) gives rise to pain that is greater than the neuroma pain, then that subject should in most instances be excluded.
✕. Signs of arterial insufficiency in the feet.
✕. Ulcer and/or wound in the foot affected by the neuroma.

What they're measuring

Evaluate the safety and tolerability of a single injection of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events

Timeframe: up to 6 months post injection

Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests

Timeframe: up to 2 weeks post injection

Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in sensory and motor examination of the foot

Timeframe: up to 6 months post injection

Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes at injection site by Injection site assessment 5-point scale for erythema and edema

Timeframe: 1, 2, and 4 hours post injection